Visipaque

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/3/2022
Visipaque Side Effects Center

What Is Visipaque?

Visipaque (iodixanol) Injection is a radiographic contrast medium indicated for intra-arterial digital subtraction angiography, angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography. Visipaque Injection intravenous is indicated for CECT imaging of the head and body, excretory urography, and peripheral venography.

What Are Side Effects of Visipaque?

Common side effects of Visipaque include:

  • headache,
  • dizziness,
  • nervousness,
  • nausea,
  • vomiting,
  • pain/warmth/cold feeling where the medicine was injected,
  • numbness or tingly feeling,
  • unusual or unpleasant taste in your mouth,
  • skin redness or itching, or
  • sleep problems (insomnia)

Dosage for Visipaque

The dose of Visipaque depends on the body weight of the patient and the procedure being performed.

What Drugs, Substances, or Supplements Interact with Visipaque?

Visipaque may interact with other drugs. Tell your doctor all medications and supplements you use.

Visipaque During Pregnancy or Breastfeeding

It is unknown how Visipaque may affect a fetus. Tell your doctor if you are pregnant or plan to become pregnant before Visipaque is administered. It is unknown if Visipaque passes into breast milk. Many injectable contrast agents pass into breast milk and breastfeeding is not recommended.

Additional Information

Our Visipaque (iodixanol) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Visipaque Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • swelling, rapid weight gain, little or no urinating;
  • wheezing or trouble breathing;
  • a seizure (convulsions);
  • thyroid symptoms--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Common side effects may include:

  • pain or warm feeling when the medicine is injected;
  • dizziness, spinning sensation;
  • numbness or tingly feeling;
  • vision changes;
  • sleep problems (insomnia);
  • headache, migraine;
  • chest pain;
  • nausea, vomiting, diarrhea;
  • agitation, anxiety, nervousness;
  • skin rash, itching; or
  • changes in your sense of taste or smell.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Visipaque (Iodixanol Injectable Contrast Medium for for Intravascular Use)

QUESTION

About how much does an adult human brain weigh? See Answer
Visipaque Professional Information

SIDE EFFECTS

Adverse Events

VISIPAQUE (iodixanol) Injection was administered to 1244 patients. The comparators administered to 861 patients included low osmolar nonionic, and high and low osmolar ionic contrast media. For complete demographics, see Clinical Trials section. Serious, life-threatening and fatal reactions have been associated with the administration of iodine-containing contrast media, including VISIPAQUE Injection. In clinical trials, 3/1244 patients given VISIPAQUE Injection and 1/861 patients given a comparator died within 5 days or later after drug administration. Also, 7/1244 patients given VISIPAQUE Injection and 8/861 given a comparator had serious adverse events.

Rare reports of anaphylaxis have been documented during postmarket surveillance. As with other contrast agents, VISIPAQUE is often associated with sensations of discomfort, warmth or pain. In a subgroup of 1259 patients, for whom data are available; similar percentages of patients (30%) who received VISIPAQUE or a comparator had application site discomfort, pain, warmth or cold. VISIPAQUE had a trend toward fewer patient reports of moderate or severe pain or warmth; however, whether or not this related to the dose, rate of administration, site of injection or concentration has not been determined.

The following table of incidence of events is based upon blinded, controlled clinical trials with VISIPAQUE Injection in controlled clinical studies in which VISIPAQUE (1244 patients) was compared with low osmolar nonionic (iohexol, iopromide), a low osmolar ionic (ioxaglate), and a high osmolar ionic (diatrizoate) contrast agents. This listing includes all reported adverse events regardless of attribution. Adverse events (AEs) are listed by body system and in decreasing order of occurrence greater than 0.5% in the VISIPAQUE group.

As the table shows, one or more adverse events were recorded in 248 of 1244 (20%) patients during the clinical trials, with the administration of VISIPAQUE Injection or within the defined duration of the study follow-up period (24 to 72 hours). In intravenous and intra-arterial procedures, the incidence and type adverse reaction was similar to those of the studied nonionic comparators (iohexol). In a 757 patient subgroup for which data are available, women reported more adverse events 83/299 (27.8%) than men 77/458 (16.2%). Women reported more chest pain (9/299 or 3%) than men (4/458 or 0.8%).

EACH ADVERSE EVENT REPORTED IN CONTROLLED CLINICAL TRIALS IN GREATER THAN 0.5% OF THE ADULT VISIPAQUE INJECTION PATIENTS

NUMBER OF PATIENTS EXPOSED VISIPAQUE
N=1244
Pooled Comparators
N=861
Number of Patients With Any Adverse Event 248 (19.9%) 194 (22.5%)
Body As a Whole Patients With Any Event 41 (3.3%) 22 (2.6%)
Edema (any location) 7 (0.6%) 0 (0%)
Cardiovascular Patients With Any Event 37 (3.0%) 39 (4.5%)
Angina Pectoris/Chest Pain 28 (2.2%) 22 (2.6%)
Gastrointestinal Patients With Any Event 51 (4.1%) 46 (5.3%)
Diarrhea 7 (0.6%) 6 (0.7%)
Nausea 35 (2.8%) 32 (3.7%)
Vomiting 10 (0.8%) 11 (1.3%)
Nervous System Patients With Any Event 101 (8.1%) 60 (7.0%)
Agitation, Anxiety, Insomnia, Nervousness 10 (0.8%) 0 (0%)
Dizziness 8 (0.7%) 8 (0.9%)
Headache/Migraine 31 (2.5%) 15 (1.7%)
Paresthesia 12 (1.0%) 1 (0.1%)
Sensory Disturbance 10 (0.8%) 9 (1.0%)
Syncope 8 (0.6%) 1 (0.1%)
Vertigo 30 (2.4%) 20 (2.3%)
Skin Patients With Any Eventa 42 (4.6%) 18 (2.1%)
Nonurticarial Rash or Erythema 26 (2.1%) 4 (0.5%)
Pruritus 20 (1.6%) 3 (0.3%)
Urticaria 6 (0.5%) 10 (1.2%)
Special Senses Patients With Any Event 57 (4.6%) 38 (4.4%)
Parosmia 6 (0.5%) 4 (0.5%)
Taste Perversion 43 (3.5%) 32 (3.7%)
Scotoma 14 (1.1%) 2 (0.2%)
a Does not include application site.

The following selected adverse events were reported in ≤ 0.5% of the 1244 patients in controlled clinical trials who received VISIPAQUE Injection.

Body as a Whole—General Disorders: back pain, fatigue, malaise.

Cardiovascular Disorders: arrhythmias, cardiac failure, conduction abnormalities, hypotension, myocardial infarction.

Nervous System: cerebral vascular disorder, convulsions, hypoesthesia, stupor, confusion.

Gastrointestinal System Disorders: dyspepsia.

Hypersensitivity Disorders: pharyngeal edema.

Respiratory System Disorders: asthma, bronchitis, dyspnea, pulmonary edema, rhinitis.

Renal System Disorders: abnormal renal function, acute renal failure, hematuria.

Peripheral Vascular Disorders: flushing, peripheral ischemia.

Skin and Appendage Disorders: hematoma, increased sweating.

Special Senses, Other Disorders: tinnitus.

Vision Disorders: abnormal vision.

Additional adverse events reported in other clinical studies and in foreign postmarketing surveillance and foreign clinical trials with the use of VISIPAQUE Injection are: anaphylactic reactions, anaphylactoid reactions, hypoglycemia, amnesia, cardiac arrest, hypertension, dyskinesia, hemorrhage not otherwise specified, polymyalgia rheumatica, pulmonary embolism, respiratory depression, and cortical blindness.

Pediatrics

For demographics, see Pediatric Use section.

The overall character, quality, and severity of adverse reactions in pediatric patients is similar to that reported in adult populations from domestic and foreign postmarketing surveillance and other information. Selected commonly reported adverse events in pediatrics include: vomiting, nausea, fever, rash, and pruritus. Less frequently reported events are apnea, disseminated intravascular coagulation, atrioventricular block and bundle branch block, arrhythmia, cardiac failure, renal failure and taste perversion.

Read the entire FDA prescribing information for Visipaque (Iodixanol Injectable Contrast Medium for for Intravascular Use)

© Visipaque Patient Information is supplied by Cerner Multum, Inc. and Visipaque Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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